Key result
This study protocol outlines a planned triple-blinded randomized clinical trial to evaluate an Android-based self-management application for stroke patients, with no results available yet.
Why the study?
Stroke is a leading cause of death and long-term disability, and self-care applications may be potentially effective in improving chronic conditions.
RCT (n=60)
Triple-blind
Permuted Block Randomization
No
RCT protocol for stroke self-care app; leaves open efficacy until results confirm benefits or guide adoption.
Background: Stroke is known as the second leading cause of death and the main leading cause of long-term disabilities in the world. Self-care applications can be potentially effective in improving chronic conditions. This protocol will be implemented for a study to evaluate the effects of an Android-based self-care application on patients with stroke. Methods: The first stage will include the development of an android-based application and second stage will be conducted using triple blinded Randomized Clinical Trial (RCT). The sample size will include 60 patients with recent stroke and partial paralysis of limbs (hemiplegia or hemiparesis), who will be divided into two groups of intervention and control through permuted block randomization method. Patients in both groups will receive usual medical care, but those in the intervention group will also use an Android-based self-management application for a period of two months and a total of 40 sessions. Outcomes will be assessed using valid and reliable questionnaires. Discussion: Assessed outcomes will include stroke severity using National Institute of Health Stroke Scale (NIHSS) score, ability to perform activities of daily living using Barthel Index (BI) score, depression rate using Beck Depression Inventory (BDI-II) score, quality of life using EQ-5D-3L score, medication adherence using Modified Morisky Scale (MMS-8) score, patient satisfaction using Patient Satisfaction Questionnaire (PSQ) score and the number and type of complications in patients into two groups. These outcomes will be assessed at baseline, after two months and after three months from the beginning of the intervention. Intervention effects on the measured variables will also be evaluated using appropriate statistical tests based on the type of variable distribution. Potential consequences of the study might be the improvement of the measured variables in the intervention group compared to the control group. The initial expectations are that the intervention may significantly improve the status of the measured variables in the intervention group compared to that of the control group. Trial registration: This protocol is registered in the Iranian registration of clinical trial (IRCT) on November 7, 2020 with the code IRCT20201015049037N1. URL: https://irct.ir/trial/51674
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Tadayon et al. (2021) conducted an RCT in Stroke (n=60). Android-based self-management application vs. Usual medical care and a sham application was evaluated on Stroke severity (NIHSS), activities of daily living (BI), depression (BDI-II), quality of life, medication adherence, patient satisfaction, and complications. This study protocol outlines a planned triple-blinded randomized clinical trial to evaluate an Android-based self-management application for stroke patients, with no results available yet.
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